NCT07875998
Study on Clinical Characteristics of Patients With Probable Alzheimer's Dementia Stratified by Blood Biomarkers
Recruiting · Not specified · Tianjin Anding Hospital · registry updated 2026-10-15
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a prospective, observational cohort study. The primary objective is to characterize the clinical features and mechanisms of behavioral and psychological symptoms of dementia (BPSD) in patients with probable Alzheimer's disease (AD) who are plasma p-Tau217 negative, and to compare them with p-Tau217-positive patients. After grouping participants by an authoritative p-Tau217 cutoff value, the negative and positive groups will be systematically compared across all 12 domains of the Neuropsychiatric Inventory (NPI). Participants will be followed up at 6, 12, and 18 months to compare the incidence of cognitive decline, new-onset severe BPSD (hallucinations, agitation/aggression, depression, etc.), cerebrovascular events, and hospitalization between the two groups. As an exploratory objective, baseline BPSD domains combined with imaging (white matter hyperintensity burden) and blood biomarkers (NfL, IL-6, GFAP, etc.) will be used to construct a simple prognostic risk-stratification model within the negative group and to validate its predictive performance....
Inclusion
- Aged between 50 and 90 years, without gender restriction;
- Meet the diagnostic criteria for probable Alzheimer's disease dementia (probable AD) proposed by the National Institute on Aging and Alzheimer's Association (2011 NIA-AA);
- Mini-Mental State Examination (MMSE) score \< 24;
- Clinical Dementia Rating (CDR) score \> 0.5;
- Hachinski Ischemic Scale score ≤ 4 (to exclude prominent vascular contributions);
- Understand the entire study procedure; written informed consent is obtained from participants or their legal guardians.
Exclusion
- Established diagnosis of vascular dementia, frontotemporal dementia, dementia with Lewy bodies, or neurocognitive disorders attributable to other etiologies;
- Concomitant definite neurological diseases;
- Presence of severe and unstable somatic diseases involving the respiratory, circulatory, immune, endocrine or other systems.